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The public sector in many, if not all, countries hold large amounts of data about people - including citizens, migrants and visitors - which interact with public services such as health, education, social security. Accessing this data - much of which will constitute ‘personal data’ i.e., data about identified or identifiable individuals - may bring various benefits for research, public service delivery and may also result in corporate profits being generated if private companies can access the data. Granting access to this data may also lead to better transparency and checks and balances within institutions of power in a country. Various governments, including the Scottish Government, have open data policies and initiatives but this mainly relates to the sharing and opening up of non-personal data. Personal data, regulated in many countries by data protection legislation, constitutional / human rights to privacy and other frameworks, poses more complications for ‘opening’ up access beyond the public sector and even data sharing within the public sector. In this discussion paper we outline some of the context, issues and challenges we have encountered in the 'Unlocking the Value of Data' (UVOD) Programme and associated Independent Expert Group (IEG) work so far and set out the intended next steps for the IEG and UVOD programme. This paper will reflect on some of the processes used in the UVOD work, focusing on the IEG activities. We will focus on how the related concepts of ‘the public interest’ and ‘public benefit’ have been taken account of in the work progressed under the auspices of the Programme, and where the term ‘value’ is predominantly defined through citizen-centred concerns that include issues such as equality, informed consent, agency, and practice, among others. We use these nuanced terms (and, in particular, ‘the public interest’ and ‘public benefit’) to also connect to academic and practice-based discussions about if and how public sector (personal) datasets can be brokered to be accessed by the private sector in ways which generate public trust and produce public benefit. We will highlight any lessons from the Scottish case we are involved in which might inform decision-making in this area more generally. Please note that these are our views as independent academic researchers and do not represent the views of the IEG and/or the Scottish Government.

This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects., This article analyses a hitherto largely obscured feature of regulatory environments in health research; namely, the role of regulatory stewardship. Through examples drawn from research ethics committees, emerging technologies, and governance of research resources, it outlines the essential features of regulatory stewardship, and argues that this concept can demonstrate considerable added value for all parties in delivering and benefiting from efficient and effective navigation of regulatory landscapes. It offers an exposition of the normative principles and associated responsibilities of the concept. The extant invisibility of regulatory stewardship requires fuller recognition and better integration of the approach into the effective functioning of law and regulation in the health research context.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance., Journal of Medical Ethics, ISSN:0306-6800

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

New models of data governance for health data are a focus of growing interest in an era of challenge to the social licence. In this article, we reflect on what the data trust model, which is founded on principles of participatory governance, can learn from experiences of involving and engagement of members of the public and participants in the governance of large-scale biobanks. We distinguish between upstream and ongoing governance models, showing how they require careful design and operation if they are to deliver on aspirations for deliberation and participation. Drawing on this learning, we identify a set of considerations important to future design for data trusts as they seek to ensure just, proportionate and fair governance. These considerations relate to the timing of involvement of participants, patterns of inclusion and exclusion, and responsiveness to stakeholder involvement and engagement. We emphasise that the evolution of governance models for data should be matched by a commitment to evaluation.

New models of data governance for health data are a focus of growing interest in an era of challenge to the social licence. In this article, we reflect on what the data trust model, which is founded on principles of participatory governance, can learn from experiences of involving and engagement of members of the public and participants in the governance of large-scale biobanks. We distinguish between upstream and ongoing governance models, showing how they require careful design and operation if they are to deliver on aspirations for deliberation and participation. Drawing on this learning, we identify a set of considerations important to future design for data trusts as they seek to ensure just, proportionate and fair governance. These considerations relate to the timing of involvement of participants, patterns of inclusion and exclusion, and responsiveness to stakeholder involvement and engagement. We emphasise that the evolution of governance models for data should be matched by a commitment to evaluation.

This chapter provides an introduction to the concept of ‘the public interest’ in health research regulation (HRR). It considers two key ways that the public interest is constructed in HRR: namely as a legal device and through empirical evidence of the views of publics. To appreciate the scope of this concept, the public interest is set in its broader context, i.e. beyond HRR, highlighting that, historically, it has been a contested concept that is difficult to define in the abstract. Next, the public interest is situated within HRR, paying attention first to how it features in the HRR legal landscape and then how this is constructed through the views of publics (with specific reference to the use of identifiable health data for research). Both conceptualisations are analysed with reference to the key challenges and opportunities that they present before a holistic concept of the public interest in HRR is proposed and consideration given to how this may be operationalised in practice.

This final chapter of the Cambridge Handbook of Health Research Regulation revisits the question posed in the Introduction to the volume: What could a Learning Health Research Regulation System look like? The discussion is set against the background of debates about the nature of an effective learning healthcare system,1 building on the frequently expressed view that any distinction between systems of healthcare and health research should be collapsed or at the very least minimised as far as possible. The analysis draws on many of the contributions in this volume about how health research regulation can be improved, and makes an argument that a framework can be developed around a Learning Health Research Regulation System (LHRRS). Central to this argument is the view that successful implementation of an LHRRS requires full integration of insights from bioethics, law, social sciences and the humanities to complement and support the effective delivery of health and social value from advances in biomedicine, as well as full engagement with those who regulate, areregulated, and are affected by regulation.

When the use of embryos in vitro for research was regulated under the Human Fertilisation and Embryology Act 1990 (as amended), regulators tried to navigate the various thresholds that occur in embryonic and research processes through providing clear-cut boundaries – the most well-known of these being the 14-day rule. This chapter offers an examination of this rule as a contemporary example of an existing mechanism in health research that is being pushed to its scientific limits. This steadfast legal boundary, faced by a relatively novel challenge, requires reflection on appropriate regulatory responses to embryo research, including the revisitation of ethical concerns, and an examination of the acceptability of carrying out research on embryos for longer than 14 days ? I argue that recognising the inherent link between processes and the regulation of the margins of human life, enables us to ask us to ask more nuanced questions about what we want for future frameworks, for example, ‘when is human?’, one that legal discussion often shies away from. Instead I will argue that viewing regulation of embryo research as instance of both processual regulation and regulating for process has the potential to disrupt existing regulatory paradigms in embryo research, and enable us to think about how we can, or perhaps whether we should, implement lasting frameworks in this field.

The principal objective of this volume is to provide the first-ever integrated, multidisciplinary and cross-cutting analysis of health research regulation, drawing on experiences and expertise from across the globe. The book confronts the gaps between documented law and regulation in action; it demonstrates the relevance and value of ethical and social theories to good governance in research, and it seeks to capture and capitalise on lessons learned from research practice. This chapter provides an account of the changing landscape of health research regulation since the millennium, exposing themes and issues that become the focus of the subsequent sections and chapters of the book. Together, the contributions lay the foundation for the development of a Learning Health Research Regulation System, and the potential elements of such a system are explored in the Afterword.

Global health emergencies (GHEs) are situations of heightened and widespread health crisis, that usually require the attention and mobilisation of actors and institutions beyond national borders. Conducting research in such contexts is both ethically imperative and requires particular ethical and regulatory scrutiny. While global health emergency research (GHER) serves a crucial function of learning how to improve care and services for individuals, it is difficult to fully capture the range of ethical considerations that arise, let alone provide a one-size-fits-all solution to such question. Using illustrations drawn from research projects conducted during GHEs, in this chapter we discuss key ethical issues and governance implications of GHER, beyond those traditionally associated with biomedical research, and explore the future direction of oversight for GHER. After setting out the complex context of GHER, we illustrate the various ethical issues associated with research and in justifying research, including considerations related to context, social value and engagement with the affected communities. Finally, we explore some of the new orientations and lenses in the governance of GHER through recent guidelines and developing practices.

Enabling researchers’ access to large volumes of health data collected in both research and healthcare settings can accelerate improvements in clinical practice and public health. Because the source and subject of those data are people, data access governance has been of concern to scientists, ethics and regulatory scholars, policy-makers and citizens worldwide. This chapter examines the topic of data access governance. We discuss the underlying values and goals of data access governance, focusing in particular on the scientific and social implications for open access and data sharing, on the rights and interests of data subjects as well as those of data producers, and on the ethical conduct of data sharing. We then present existing data access arrangements of organisations and repositories that exemplify varying modes of good practice. We argue these models exemplify the tension between promoting open access to databases on the one hand, and, on the other, protecting the rights and interests of the parties involved, including data subjects, researchers, funding organizations and commercial entities. We suggest that principles of transparency, fairness and proportionality in consideration of all stakeholders’ interests and values is key to achieving this balance.

In this chapter, I will argue that there is a political dimension to research, and that accounts of health research regulation that ignore political relations between stakeholders are therefore incomplete. The concept of vulnerability – particularly vulnerability to exploitation – provides the grit around which the claims are built. This is because vulnerability is an inescapable part of human life; because research participation may magnify vulnerability, even while health research itself promises to mitigate certain vulnerabilities (most directly vulnerability to illness, but indirectly vulnerability to economic hardships that may follow therefrom); and because vulnerability is manifested in, exacerbated by, or mitigated through, inherently political relationships with others, the groups and communities of which we are a part, and in the context of which all research takes place. I shall not be making any normative claims about research regulation here, save for the suggestion that decision-makers ought to take account of latent political aspects in their deliberations. For the most part, I shall simply attempt to sketch out some of those political aspects.

Governments and stakeholders have struggled to find a common ground on how to regulate research for different (‘proven’ or ‘unproven’) practices. Research on traditional, alternative and complementary medicines is often characterised as following weak research protocols and as producing evidence too poor to stand the test of systematic reviews, thus rendering individual case studies results insignificant. Although millions of people rely on traditional and alternative medicine for their primary care needs, the regulation of research into, and practice of, these therapies is governed by biomedical parameters. This chapter asks how, despite efforts to accommodate other forms of evidence, regulation of research concerning traditional and alternative medicines is ambiguous as to what sort of evidence – and therefore what sort of research – can be used by regulators when deciding how to deal with practices that are not based on biomedical epistemologies. Building on ideas from science and technology studies (STS), in this chapter we analyse different approaches to the regulation of traditional and non-conventional medicines adopted by national, regional and global governmental bodies and authorities, and we identify challenges to the inclusion of other modes of ‘evidence’ based on traditional and hybrid epistemologies.

In recent times, biomedical research has begun to tap into larger-than-ever collections of different data types. As a consequence, the notion of health data – data that are of relevance for health-related research or for clinical purposes – is expanding to include a variety of non-clinical data, as well as data provided by research participants themselves through commercially available products such as smartphones and fitness bands. To date, most scholarship and policy on these issues has focused on privacy and data protection. Less attention has been paid to addressing other aspects of the wicked challenges posed by big data health research and even less work has been geared towards the development of novel governance frameworks. In this chapter, we make the case for adaptive and principle-based governance of big data research. We outline six principles of adaptive governance for big data research and propose key factors for their implementation into effective governance structures and processes., Cambridge Law Handbooks, The Cambridge Handbook of Health Research Regulation, ISBN:978-1-108-47597-6, ISBN:978-1-108-62002-4

The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core.